NicVAX is an experimental therapy for the treatment of nicotine addiction and the prevention of smoking relapse. The vaccine is designed to stimulate the immune system to produce antibodies that bind to the nicotine molecules. Once bound together, they are too large to cross the blood-brain barrier. In this way, the nicotine is blocked from reaching the receptors in the brain that cause the highly-addictive pleasure sensation experienced by smokers and users of nicotine products. When nicotine is prevented from supplying them the sensation they crave, smokers have an easier time kicking the habit.

"If approved, this smoking cessation vaccine technology could be a novel solution to help the millions of smokers who want to stop smoking and remain abstinent; a habit that is well documented to be very hard to stop permanently," said Jean Stephenne, president of GSK Biologicals.

Indeed, smokers who try to stop often relapse. According to Nabi, pre-clinical and clinical data show that NicVAX can help people quit smoking. But what's also crucial is that because the antibodies remain in the blood stream for 6 to 12 months, Nabi believes the vaccine could also be effective in preventing smoking relapse. Currently available smoking cessation therapies, the companies said, have relapse rates that can be as high as 90% in the first year after a smoker quits.
A Potential Market of $2 Billion

On Sept. 29, Nabi announced it received a $10 million grant from the U.S. National Institute on Drug Abuse for the continued development of NicVAX. That followed an earlier grant from the agency, as well as a Fast Track designation from the U.S. Food and Drug Administration. As a result, Nabi has decided to proceed with its Phase III trial, the protocol of which has already been agreed upon with the FDA.

Following that, Nabi started the first of two late-stage trials of NicVAX, with Glaxo holding the rights on development work past late-stage trials. In parallel with the Phase III studies, and independent of whether it exercises its option to in-license NicVAX, GSK will be developing a next-generation nicotine vaccine based on Nabi's intellectual property together with GSK's own technology.

Estimates of the number of smokers worldwide range from 1.2 billion to 1.3 billion, and it is agreed that tobacco use is the leading cause of preventable death in the world: 5.4 million deaths per year worldwide. In the U.S., an estimated 43.4 million adults currently smoke cigarettes, and tobacco smoking is responsible for approximately 443,000 deaths each year. The estimated direct and indirect costs associated with smoking exceed $193 billion annually. Nearly 75% of smokers in the U.S. report that they want to stop smoking, but fewer than 5 percent who try to do so remain tobacco-free for 3 to 12 months.

Deal details

Nabi gets $40 million up front, allowing GSK the option to exclusively license NicVAX worldwide and a license to develop follow-on next-generation nicotine vaccines using Nabi's intellectual property. Nabi is then eligible to receive over $500 million in option fees and milestones for the vaccine and possible follow-on vaccines. Nabi also gets double-digit royalties on sales of NicVAX, as well as as royalties on next-generation nicotine vaccines should Glaxo exercise its option to in-license NicVAX.